Transcript Overview on Medicines Regulation: regulatory cooperation and harmonization in the focus Dr Samvel Azatyan Manager, Medicines Regulatory Support Programme Quality Assurance and Safety: Medicines Essential Medicines.

Overview on Medicines Regulation:
regulatory cooperation and
harmonization in the focus
Dr Samvel Azatyan
Manager, Medicines Regulatory Support Programme
Quality Assurance and Safety: Medicines
Essential Medicines and Pharmaceutical Policies
World Health Organization
E-mail: [email protected]
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Why regulation of medicines is needed?
What is special with medicines, compared to other goods /
commodities?
 As a rule, patients are not able to make independent
judgement about of the QUALITY, SAFETY and EFFICACY;
─ Even health professionals have difficulties, unless they are
specially trained;
Medicines regulation is the totality of all measures - legal,
administrative and technical - which governments undertake
to ensure the quality, efficacy and safety of medicines, as
well as the relevance and accuracy of the product
information.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Why regulation of medicines is needed?
Consequences of under-regulation due
to the weak regulatory capacity
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irrational consumption and prescription;
quality of medicines is not assured - substandard,
counterfeit, harmful, useless medicines on the market.
Consequences of over- or improper regulation
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shortage of needed medicines or delayed access;
increased costs of medicines due to the cost of
regulatory system.
Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Rationale for Government's role
 Governments are obliged to intervene in the activities
of the pharmaceutical sector due to public health and
safety concerns;
 In this context, medicines regulation is a public policy
that restricts private sector activities in order to
attain social goals identified by the State;
Medicines regulation in the countries is performed
through National Medicines Regulatory Authorities
(NMRAs)
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Medicines regulatory authority
In a broad sense medicines regulatory authority means a
network (institution) that administers the full spectrum of
drug regulatory activities, including at least the following functions:
 Marketing authorization for new products and variation of existing
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authorizations;
GMP, GCP, GLP inspections;
Licensing and post-license control of manufacturers, wholesalers and
other distribution channels;
Quality control laboratory testing;
Adverse drug reaction monitoring;
Provision of drug information and promotion of rational drug use;
Enforcement operations;
Monitoring of Drug Utilization, etc.
Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Main principles of medicines regulation
Medicines regulation should:
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Have patient in the focus;
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Be evidence based;
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Be risk oriented;
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Bring added value;
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Respect interests of stakeholders and real possibilities;
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Be transparent but respect confidentiality;
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Be effective and flexible;
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Be part of broader overall pharmaceutical policy.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Main principles of medicines regulation
…But also keep in mind, that:
 Regulations must be attuned to available resources
(technical, human, financial, etc.);
 Due to the complexity and resource constrains, the
requirements developed and successfully implemented
in one country may not be equally successful in
another country;
 The application of more sophisticated requirements
may have (at least, in short term) serious public health
implications.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Differences in regulatory capacity globally
193 WHO Member States:
For different reasons,
many regulatory
authorities do not have
the full capacity to
perform all regulatory
functions.
50%
20%
30%
Developed
Variable
Limited
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Differences in regulatory capacity
in African Region
46 WHO Member States:
33%
24%
4%
39%
Source:
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Developed
Moderate
Basic
Limited
WHO/AFRO/EDP/04.5: Availability of Drug Regulatory and Quality Assurance
Elements in Member States of the WHO African Region, 2004, Brazzaville.
Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Critical issues in regulation of medicines
 Not all regulatory functions are performed due to chronic
shortages of human, technical and financial resources;
 Different institutional arrangements exist for the
regulation of medicines:
Weak regulatory frameworks and lack of
enforcement can lead to various bottlenecks
limiting access to essential
medicines.
 Regulators are perceived as an additional "road-block" to
access to new therapies..;
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Strategies to cope with increasing demands
 Avoid doing things that do not give added value;
 Concentrate on things that do give added value;
 Be pragmatic and focus on priority issues, most relevant
for public health (risk-benefit approach);
 Increased effectiveness of internal operations
─ Quality systems, international benchmarking;
 Co-operation with partners in order to increase regulatory
capacity by elimination of duplicated activities
─ Facilitated by comparable standards and administrative
requirements.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
WHO approaches for regulatory support
 Developing evidence - assessments of regulatory systems
worldwide (around 50 NMRAs assessed in all 6 regions);
 Providing direct technical support (capacity building, tools
and guidance) to regions and countries (with PQ and IVB);
 Stimulating / initiating collaboration between
regulators from various countries on various
regulatory activities (from "North → South"
to "South ↔ South");
 Promoting harmonization.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Collaboration of MRS Programme with other
Programmes and Units within EMP and outside
HSS/EMP
FCH/IVB
QSM (PQ, Safety)
QSM (Quality
Assurance)
QSM (Blood products)
MAR (GGM)
QSS
(Regulatory pathways)
Disease-oriented
programmes
HTM/GMP
(Global Malaria
Programme)
Other Programmes
Medicines Regulatory Support
WHO Regional Offices
WHO Country Offices
National Medicines Regulatory Authorities
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Faster access to medicines through
sharing of regulatory information
MRS is working with regulators to find out how best to
build confidence in regulatory decisions taken by other
regulators, including:
─ how to facilitate exchange
of consolidated information
about assessments and
inspections;
─ without challenging their
sovereignty.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
"You kids share your food
and stop being shellfish!"
Sharing of expertise vs. recognition of
decision
Acceptance of expertise is not equal to acceptance
of decision:
 Acceptance of expertise
– is sovereign and complex regulatory decision of NRA based on
scientific arguments and confidence;
– may be applied case to case;
– is followed by formal independent decision according to national
legislation and mandate of national MRA;
 Acceptance of decision
– is a formal legal act, frequently requiring international treaties;
– may modify liabilities of involved parties and requires legal
specification of acceptance and non-acceptance.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
New regulatory approaches
Smaller or less resourced regulatory authorities more and
more starting to rely on the approvals or opinions issued by the
well-resourced regulatory authorities
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Examples of this type of initiatives include, but are not
limited to:
WHO PQP - HIV/AIDS, TB, malaria, RH, paediatric therapy;
US PEPFAR - HIV/AIDS;
EU Article 58 – assessment of products for use outside the
European Union territory;
Canada's Access to Medicines Regime – assessment of
products according to WHO Model List of Essential Medicines;
Other – orphan medicines, paediatric medicines.
Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Regulatory harmonization
In a broad sense harmonization means harmonization
of technical requirements for medicines regulation,
i.e., legislations, guidelines, procedures, etc.
 These requirements relate to the quality, safety and
efficacy of the medicinal products;
 These requirements differ in complexity, from one type
of marketing authorization application to another.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
What we do mean under Harmonization?
 True harmonization goes further than just development
of common documentation;
 It requires effective communication and collaboration
aimed at building capacity and trust (e.g.,
information sharing, recognition and joint working);
 In combination, these activities can lead to similar or
collaborative approaches to drug registration;
 Paving the way for mutual recognition and/or
centralized registration (if desired) in the longer-term
future.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
What we do not mean under Harmonization?
Harmonization doesn't mean a loss of national sovereignty / autonomy
(and certainly not in the early stages)
 Common documentation stipulates the requirements for registration;
 Better communication enables countries to chose which information
they will use;
 Collaborative mechanisms, such as joint assessments or inspections,
does not imply collaborative decision-making!
In all cases the registration decision itself
stays firmly in the hands of sovereign nations
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Potential public health gains from
harmonization
 Less risk of being harmed by medicines (safety risks
combined with no treatment effect risks) as gradual
improvement of quality, safety and efficacy of products
on the markets is expected;
 More rapid access to needed medicines (high priority
essential medicines, new medicines…);
 Better value for money (both for out of pocket and
public funds), as no waste on substandard and of poorquality medicines;
 Increasing trust in generic medicines (also better value
for money).
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
But… potential gains have to be balanced
with… potential losses
 Increased price level of medicines (quality has its
price);
 Reduced access – not all medicines on the market
may meet new harmonized standards;
 Increasing price for medicines regulation
(harmonization has its price too);
 Local industry may not always win;
 Wholesale and retail businesses may loose many of
the products that were bestsellers for them.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Potential scope for harmonization in Africa
 Harmonization of technical requirements
– Generic drugs vs NCEs – move from generics to NCEs
– Priorities (CTD, modules for generics, GMP), timeframes and
working methods for creation of guidelines to be determined;
 Implementation of harmonized technical requirements;
 Establishing for priority products a special pathway –
one set of assessments/inspections – access to all
markets
– Either via "centralized procedure" (one application, one
process and one result for all) or "mutual recognition" (same
application for all or some, one MRA does the job and others
recognize without duplication).
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Regulatory harmonization in Africa
 Africa – a continent of
huge diversity and
complex unity, with
numerous Regional
Economic Communities
(REC);
 … overlaps and
politically complicated
environment.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization
Initiative (AMRHI)
 Process started with the informal
consultations in ICDRA Meeting,
September 2008, Bern, Switzerland;
 In response to the growing
recognition of the potential benefits of
harmonizing medicines registration in
Africa, a WHO concept paper was
developed to describe a proposed
approach to supporting drug
registration harmonization within and
across African regional groupings.
WHO Drug Information, Volume 22,
Number 3, 2008
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization
Initiative (AMRHI)
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Further discussions and orientation in the meeting in
Johannesburg, South Africa, 24-26 February 2009, organized
jointly by BMGF, NEPAD, William J. Clinton Foundation and the
WHO.
The purpose of the meeting was:
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to explore the possibilities of supporting medicine registration
harmonization, as an initial first step to broader regulatory
harmonization within African Regional Economic Communities
(RECs) and organizations, and
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to initiate a strategic approach to develop project proposals for
mobilizing the necessary financial and technical resources to
support RECs undertaking medicine registration harmonization.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization
Initiative (AMRHI)
 Donor partners, NEPAD and WHO confirmed their
interest in supporting the RECs, including necessary
actions to support national implementation, strengthen
national regulatory agencies and promote inter-REC and
continental exchange of information, coordination and
technical consistency.
 Their strategic approach was to invite summary project
proposals from committed RECs and seek financial and
technical support for the most sound and promising
proposals among them.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
African Medicines Registration Harmonization
Initiative (AMRHI)
next steps for further implementation of the project:
 By 31st May 2009 RECs were invited to submit to WHO and NEPAD a
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summary project proposal in support of regional medicine registration
harmonization. A draft format and a suggested scope and outline are
available. NEPAD and WHO are willing to give limited technical support to
the development of such regional proposals.
April - May 2009: Submission of summary project proposals;
June 2009: Review of proposals and feedback to RECs;
July - October 2009: Selected RECs to submit their full project proposals
to NEPAD & WHO;
November-December 2009: Review of full project proposals by Project
consortium and submission to interested Donors;
January - June 2010: Expected start of the implementation of first
approved projects.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Conclusions
 Sharing of information, collaboration and harmonization
can help reduce workload and improve overall regulatory
performance.
 It can help to direct the expert knowledge and resources to
performance of the functions that can improve public health
and facilitate access to essential medicines;
 Formation of effective networks between regulatory authorities
nationally and internationally may facilitate sharing of scarce
resources and eliminate duplicating of activities;
 Harmonization may contribute in building regulatory capacity
and trust, which is an important achievement in its own
right.
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland
Thank you!
Photo by:
www.buildmyaudience.com
www.who.int/medicines
[email protected]
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Technical Briefing Seminar, 1 - 5 November 2010
WHO Headquarters, Geneva, Switzerland